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  • Quality and

    Flen Health works with partners and consultants to find the best solutions to develop, manufacture and distribute products with the smallest possible impact on the environment and the highest ethical standards.

Quality and Environment.

Flen Health is committed to comply with EN ISO 13485:2016 and relevant GMP guidelines. Flen Health also commits to the applicable regulatory and customer requirements and to maintain the effectiveness of the quality management system.

The scope of Flen Health’s quality management system under EN ISO 13485:2016 includes the design, development, (outsourced) manufacturing and distribution of medical devices for topical use.

Our quality policy

Flen Health develops, markets and sells medical device products. Flen Health furthermore develops pharmaceutical products.

Flen Health’s management and staff are committed to provide high-quality products that meet customer needs and official regulatory requirements. This is done by maintenance and improvement of products, services and the quality management system.

Our environmental policy

Flen Health’s operations are to be conducted with the least possible environmental impact, taking into account the company’s financial and technical resources. We must comply with laws and other relevant requirements in the environmental area that affect our operations. Within the framework of our management system, we will establish and follow up on tangible environmental objectives for the operations. The company’s environmental work should be conducted with the aim of achieving continuous improvements and preventing pollution of the environment.